The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Endotracheal Tube Introducing Guide.
| Device ID | K844557 |
| 510k Number | K844557 |
| Device Name: | ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE |
| Classification | Stylet, Tracheal Tube |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-21 |
| Decision Date | 1984-12-17 |